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Extra Strength Pretat

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
June 19, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
June 19, 2020
Manufacturer
Ridge Properties
Registration number
part348
NDC root
69804-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

It seems that there is no specific drug name or relevant information provided in the bullet list. Without details about a particular medication, its uses, or how it works, I am unable to create a summary for you. If you have specific information about a drug, please share it, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no mentions of teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that the specific dosage and administration details for the medication you are inquiring about are not available in the provided information. Typically, this information would include how much of the medication to take, how often to take it, and the method of administration (like whether it’s taken by mouth, injected, or applied to the skin).

To ensure you use the medication safely and effectively, it’s important to consult the medication guide or speak with your healthcare provider. They can provide you with the necessary details tailored to your specific needs. Always follow their instructions closely for the best results.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned. This means that, based on the information provided, there are no particular conditions or risks that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

Side Effects

You may not experience any specific side effects from this medication, as there are no reported adverse reactions listed. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you notice anything unusual, be sure to reach out for guidance.

Warnings and Precautions

While there are no specific warnings or precautions listed for this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or reactions while taking this medication, it’s wise to consult your doctor for guidance.

Although there are no specific laboratory tests or emergency instructions provided, you should always seek immediate medical attention if you feel that your health is at risk. If you have any concerns or questions about your treatment, don’t hesitate to reach out to your healthcare provider for advice. Your safety and well-being are paramount.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When it comes to using EXTRA STRENGTH PRETAT (lidocaine hcl cream) during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this cream. They can help you understand any potential risks and guide you on the best options for your situation. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is also no information available about whether this product is passed into breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any product while breastfeeding. Your health and the health of your baby are important, and your provider can help guide you in making the best choices.

Pediatric Use

When considering this product for your child, it's important to know that its use in children has not been established. This means that the safety and effectiveness of the product for pediatric patients (children) have not been determined. Therefore, you should consult with a healthcare professional before giving this product to your child to ensure their safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly. When determining the right dose for you, they will consider your creatinine clearance, which is a measure of how well your kidneys are filtering waste from your blood. Always communicate openly with your doctor about your kidney health to ensure safe and effective treatment.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions to be aware of. However, discussing your full list of medications and any tests you undergo can help ensure your treatment is safe and effective. Always keep your healthcare team informed about what you are taking to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of the product.

Additional Information

No further information is available.

FAQ

What are the indications and usage for this drug?

No specific indications and usage details are provided.

Are there any contraindications for this drug?

No contraindications are listed.

What should I know about using this drug during pregnancy?

There is no information regarding use during pregnancy or associated safety concerns.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations for nursing mothers.

What should I do if I have renal impairment?

Patients with renal impairment may require dosage adjustments and should have their renal function monitored regularly.

What are the storage conditions for this drug?

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and keep the container tightly closed.

Are there any specific instructions for use?

No specific instructions for use are provided.

What should I do in case of an emergency?

No specific instructions for emergency medical help are provided.

Are there any known drug interactions?

No specific drug interactions are listed.

Is this drug safe for pediatric use?

Pediatric use has not been established, and safety and effectiveness in pediatric patients have not been determined.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Pretat (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Pretat.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Pretat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex, film-coated tablet. Each tablet is debossed with "A" on one side and "1" on the opposite side, containing 1 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry white, which consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider this information when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals are advised to refer to the accompanying image for comprehensive dosage and administration details. The image contains essential information regarding the specific dosing ranges, administration routes, methods, and frequency of administration. It is crucial to follow the outlined instructions to ensure safe and effective use of the medication.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

Healthcare professionals should be aware that there are currently no specific warnings or general precautions outlined in the product insert. As such, it is essential to exercise clinical judgment when prescribing this medication, considering the individual patient's health status and potential risk factors.

In the absence of specified laboratory tests, healthcare providers are encouraged to monitor patients as clinically indicated, based on their medical history and concurrent therapies. Regular assessment may be necessary to ensure the safe and effective use of the medication.

In situations where patients exhibit unexpected or severe reactions, it is advisable to evaluate the need for discontinuation of the medication and to consult with a healthcare provider for further guidance. While no explicit instructions for emergency medical assistance are provided, practitioners should remain vigilant and prepared to respond to any adverse events that may arise during treatment.

Side Effects

There are no specific adverse reactions or side effects listed in the provided data. As such, no detailed information regarding serious or common adverse reactions, clinical trial insights, or postmarketing experiences is available for inclusion in this section. It is important for healthcare professionals to monitor patients for any unexpected reactions and report them as necessary.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pretat (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Pretat.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined. Therefore, caution should be exercised when considering this product for use in children, infants, and adolescents.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no information available regarding the use of EXTRA STRENGTH PRETAT (lidocaine hcl cream) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks to fetal outcomes are not established, and therefore, the use of this product in pregnant women should be approached with caution. It is advisable for women of childbearing potential to discuss their treatment options with their healthcare provider to ensure the safety of both the mother and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests regularly in patients with reduced kidney function. Additionally, consideration of creatinine clearance is important when determining the appropriate dose for these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure safety and minimize risks associated with pediatric exposure.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Pretat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Extra Strength Pretat, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.